[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04138927":3,"trial-entities:NCT04138927":341,"trial-summary:NCT04138927":344},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":38,"secondary_outcomes":49,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":67,"locations":70,"central_contacts":337,"overall_officials":338,"references":339,"see_also_links":340},"NCT04138927","C-935788-058","A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia","ENROLLING_BY_INVITATION","2024-04","2021-07","2022-03-17","2019-10-30","Rigel Pharmaceuticals","INDUSTRY",true,"The primary objective of this study is:\n\n• To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).",null,[18],"Warm Antibody Autoimmune Hemolytic Anemia",[20,18,21],"wAIHA","Warm Autoimmune Hemolytic Anemia","INTERVENTIONAL","TREATMENT",[25],"PHASE3",{"count":27,"type":28},90,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DRUG","Fostamatinib disodium","Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg.",[35],"Fostamatinib",[37,35],"R935788",[39,43,46],{"measure":40,"description":41,"timeFrame":42},"Adverse Events","Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study","104 weeks",{"measure":44,"description":45,"timeFrame":42},"Blood Pressure","Change from baseline in blood pressure over time",{"measure":47,"description":48,"timeFrame":42},"Absolute Neutrophil Count (ANC)","Change from baseline in absolute neutrophil count (ANC) over time",[50,53,56],{"measure":51,"timeFrame":52},"Achievement of Durable Hemoglobin Response","24 weeks",{"measure":54,"timeFrame":55},"Total Duration of Response","During the Intervention period up to 104 weeks",{"measure":57,"description":58,"timeFrame":55},"Corticosteroid dose","Net cumulative change from Baseline in corticosteroid dose","ALL","18 Years","100 Years",false,{"inclusion":64,"exclusion":65,"raw_text":66},[],[],"Inclusion Criteria:\n\n1. Subject must be willing and able to give written informed consent by signing an IRB approved Informed Consent Form prior to undergoing any study-specific procedures.\n2. Subject must have completed all 24 weeks of participation in the study C-935788-057.\n\nExclusion Criteria:\n\n1\\. Any subject who discontinued participation in Study C-935788-057 prior to Week 24.",[68,69],"ADULT","OLDER_ADULT",[71,80,87,95,103,111,119,127,134,143,151,159,163,171,175,183,191,198,202,210,217,225,233,236,244,251,257,264,271,279,287,294,302,310,314,322,329],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"geoPoint":77},"University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Laboratory","Los Angeles","California","90033","United States",{"lat":78,"lon":79},34.05223,-118.24368,{"facility":81,"city":82,"state":74,"zip":83,"country":76,"geoPoint":84},"Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center","Torrance","90502",{"lat":85,"lon":86},33.83585,-118.34063,{"facility":88,"city":89,"state":90,"zip":91,"country":76,"geoPoint":92},"Lombardi Comprehensive Cancer Center","Washington D.C.","District of Columbia","20007",{"lat":93,"lon":94},38.89511,-77.03637,{"facility":96,"city":97,"state":98,"zip":99,"country":76,"geoPoint":100},"John Hopkins Bayview Medical Center","Baltimore","Maryland","21205",{"lat":101,"lon":102},39.29038,-76.61219,{"facility":104,"city":105,"state":106,"zip":107,"country":76,"geoPoint":108},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":109,"lon":110},42.35843,-71.05977,{"facility":112,"city":113,"state":114,"zip":115,"country":76,"geoPoint":116},"Comprehensive Cancer Centers of Nevada","Las Vegas","Nevada","89169",{"lat":117,"lon":118},36.17497,-115.13722,{"facility":120,"city":121,"state":122,"zip":123,"country":76,"geoPoint":124},"American Oncology Network Vista Oncology Division","Olympia","Washington","98506",{"lat":125,"lon":126},47.04491,-122.90169,{"facility":128,"city":129,"state":122,"zip":130,"country":76,"geoPoint":131},"University of Washington","Seattle","98109",{"lat":132,"lon":133},47.60621,-122.33207,{"facility":135,"city":136,"state":137,"zip":138,"country":139,"geoPoint":140},"Princess Alexandra Hospital - Cancer Trials Unit","Brisbane","Queensland","4201","Australia",{"lat":141,"lon":142},-27.46794,153.02809,{"facility":144,"city":145,"state":146,"zip":147,"country":139,"geoPoint":148},"The Alfred Hospital","Melbourne","Victoria","3004",{"lat":149,"lon":150},-37.814,144.96332,{"facility":152,"city":153,"zip":154,"country":155,"geoPoint":156},"Hanusch-Krankenhaus","Vienna","1140","Austria",{"lat":157,"lon":158},48.20849,16.37208,{"facility":160,"city":153,"zip":161,"country":155,"geoPoint":162},"Universitätsklinik f. Innere Medizin I - Klin. Abt. f. Hämatologie u. Hämostaseologie","A-1090",{"lat":157,"lon":158},{"facility":164,"city":165,"zip":166,"country":167,"geoPoint":168},"Vitebsk Regional Clinical Hospital","Vitebsk","210037","Belarus",{"lat":169,"lon":170},55.1904,30.2049,{"facility":172,"city":165,"zip":173,"country":167,"geoPoint":174},"Vitebsk Regional Clinical Oncology Dispensary","210603",{"lat":169,"lon":170},{"facility":176,"city":177,"zip":178,"country":179,"geoPoint":180},"AZ Nikolaas","Sint-Niklaas","9100","Belgium",{"lat":181,"lon":182},51.16509,4.1437,{"facility":184,"city":185,"zip":186,"country":187,"geoPoint":188},"University Multiprofile Hospital for Active Treatment \"Sveti Georgi\" EAD, Plovdiv, Clinic of Medical oncology","Pleven","5800","Bulgaria",{"lat":189,"lon":190},43.41791,24.61666,{"facility":192,"city":193,"zip":194,"country":187,"geoPoint":195},"University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Varna, Clinic of Clinical Haematology","Sofia","1431",{"lat":196,"lon":197},42.69751,23.32415,{"facility":199,"city":193,"zip":200,"country":187,"geoPoint":201},"Specialized Hospital for Active Treatment of Hematological Disease EAD,","1756",{"lat":196,"lon":197},{"facility":203,"city":204,"zip":205,"country":206,"geoPoint":207},"Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika","Brno","625 00","Czechia",{"lat":208,"lon":209},49.19522,16.60796,{"facility":211,"city":212,"zip":213,"country":206,"geoPoint":214},"Fakultni nemocnice Ostrava Klinika hematoonkologie","Ostrava","70852",{"lat":215,"lon":216},49.83465,18.28204,{"facility":218,"city":219,"zip":220,"country":221,"geoPoint":222},"CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses","Pessac","33603","France",{"lat":223,"lon":224},44.80565,-0.6324,{"facility":226,"city":227,"zip":228,"country":229,"geoPoint":230},"LTD Multiprofile Clinic Consilium Medulla","Tbilisi","0186","Georgia",{"lat":231,"lon":232},41.69143,44.83412,{"facility":234,"city":227,"zip":228,"country":229,"geoPoint":235},"M. Zodelava Hematology Centre, Tbilisi",{"lat":231,"lon":232},{"facility":237,"city":238,"zip":239,"country":240,"geoPoint":241},"Universitätsklinikum Essen","Essen","45147","Germany",{"lat":242,"lon":243},51.45657,7.01228,{"facility":245,"city":246,"country":247,"geoPoint":248},"Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Ematologia","Milan","Italy",{"lat":249,"lon":250},45.46427,9.18951,{"facility":252,"city":246,"zip":253,"country":247,"geoPoint":254},"Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia","20122",{"lat":255,"lon":256},42.78235,12.59836,{"facility":258,"city":259,"zip":260,"country":247,"geoPoint":261},"SCDU Ematologia AOU \"Maggiore della Carità\"","Novara","28100",{"lat":262,"lon":263},45.44694,8.62118,{"facility":265,"city":266,"country":267,"geoPoint":268},"Academisch Medisch Centrum","Amsterdam","Netherlands",{"lat":269,"lon":270},52.37403,4.88969,{"facility":272,"city":273,"zip":274,"country":275,"geoPoint":276},"Haukeland University Hospital","Bergen","5021","Norway",{"lat":277,"lon":278},60.39299,5.32415,{"facility":280,"city":281,"zip":282,"country":283,"geoPoint":284},"National Research Center for Hematology","Moscow","125167","Russia",{"lat":285,"lon":286},55.75204,37.61781,{"facility":288,"city":289,"zip":290,"country":283,"geoPoint":291},"State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory","Sochi","354057",{"lat":292,"lon":293},43.59699,39.72477,{"facility":295,"city":296,"zip":297,"country":298,"geoPoint":299},"Clinical Centre of Vojvodina, Clinic for Hematology","Novi Sad","21000","Serbia",{"lat":300,"lon":301},45.25167,19.83694,{"facility":303,"city":304,"zip":305,"country":306,"geoPoint":307},"Hospital Vall d'Hebron","Barcelona","08035","Spain",{"lat":308,"lon":309},41.38879,2.15899,{"facility":311,"city":304,"zip":312,"country":306,"geoPoint":313},"Hospital Clinic de Barcelona","08036",{"lat":308,"lon":309},{"facility":315,"city":316,"zip":317,"country":318,"geoPoint":319},"City Clinical Hospital № 4, Hematology Center","Dnipro","49102","Ukraine",{"lat":320,"lon":321},48.46664,35.04066,{"facility":323,"city":324,"zip":325,"country":318,"geoPoint":326},"Kyiv City Clinical Hospital №9, hematology department №1","Kyiv","04112",{"lat":327,"lon":328},50.45466,30.5238,{"facility":330,"city":331,"zip":332,"country":333,"geoPoint":334},"Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust","Liverpool","L7 8XP","United Kingdom",{"lat":335,"lon":336},53.41058,-2.97794,[],[],[],[],{"nct_id":4,"conditions":342,"biomarkers":343},[18],[],{"nct_id":4,"found":14,"summary":345,"prompt_version":355},{"design":346,"status":347,"heading":348,"summary":349,"follow_up":350,"word_count":351,"commitments":352,"compensation":353,"drugs_mentioned":354},"This is an open-label study, meaning you and your doctors will know you are receiving fostamatinib disodium. It plans to include 90 participants.","completed","Fostamatinib for Warm Antibody Autoimmune Hemolytic Anemia (wAIHA)","This study is testing the long-term safety of a drug called fostamatinib disodium for people with warm antibody autoimmune hemolytic anemia (wAIHA). wAIHA is a condition where your body's immune system mistakenly attacks and destroys your red blood cells. Fostamatinib disodium comes in 100 mg and 150 mg doses. The study aims to see how safe fostamatinib is over time by tracking side effects, blood pressure, and a type of white blood cell called Absolute Neutrophil Count (ANC) for up to 104 weeks. You can join if you are 18 to 100 years old and have already completed 24 weeks of a previous study (C-935788-057) with this drug. The study plans to enroll 90 participants, but its current status is unclear.","Your safety will be followed for up to 104 weeks, measuring adverse events, blood pressure, and Absolute Neutrophil Count (ANC).",121,"To join, you must have completed 24 weeks of a previous study (C-935788-057). The study will track your safety for up to 104 weeks.","Not stated in the trial record.",[32],"v2"]